证券代码：688062 证券简称：迈威生物 迈威（上海）生物科技股份有限公司 投资者关系活动记录表 编号：2023-09-02 特定对象调研 □分析师会议 □媒体采访 □业绩说明会 投资者关系 活动类别 □新闻发布会 路演活动 现场参观 其他 证券公司策略会 参与单位 中信建投、国海证券、东方证券、华福证券、兴业基金、天治基 金、安信基金、南方基金、天风证券、星石投资、东北证券、汇升 投资、汐泰投资、兴证资管、南土资产、中欧基金、开源证券、鹤 ...

海通证券股份有限公司 关于迈威（上海）生物科技股份有限公司 2023 年半年度持续督导跟踪报告 | 保荐机构名称：海通证券股份有限公司 | 被保荐公司简称：迈威生物 | | --- | --- | | 保荐代表人姓名：王永杰、陈新军 | 被保荐公司代码：688062 | 经中国证券监督管理委员会《迈威（上海）生物科技股份有限公司首次公开 发行股票注册的批复》（证监许可[2021]3859 号）核准，迈威（上海）生物科技 股份有限公司（以下简称"上市公司"、"公司"或"发行人"）首次公开发行 股票 9,990 万股，每股面值人民币 1 元，每股发行价格人民币 34.80 元，募集资 金总额为人民币 347,652.00 万元，扣除发行费用后，实际募集资金净额为人民币 1 330,343.22 万元。本次发行证券已于 2022 年 1 月 18 日在上海证券交易所上市。 海通证券股份有限公司（以下简称"保荐机构"或"海通证券"）担任其持续督 导保荐机构，持续督导期间为 2022 年 1 月 18 日至 2025 年 12 月 31 日。 在 2023 年 1 月 1 日至 2023 年 6 月 30 日持续督导期 ...

Drug Development and Research - The drug application for 9MW0321 has been accepted by the National Medical Products Administration in December 2021, with expectations for approval in 2023; failure to obtain approval may adversely affect the company's sales revenue and overall business outlook [8]. - The company invested significant funds in R&D, with expenses of approximately CNY 581.33 million in 2020, CNY 622.51 million in 2021, CNY 758.61 million in 2022, and CNY 340.43 million in the first half of 2023, indicating a continuous commitment to pipeline development [21]. - The company has 12 ongoing research projects, requiring sustained large-scale R&D investments for preclinical studies, clinical trials, and new drug preparations [21]. - Mabwell focuses on the development of biosimilars and innovative drugs targeting mature targets, aiming to meet unmet clinical needs globally [17]. - The company is developing multiple monoclonal antibodies, including 9MW1111 (anti-PD-1), 9MW1411 (anti-α-toxin), and 9MW1911 (anti-ST2) for various therapeutic applications [35]. - The company has initiated the development of antibody-drug conjugates such as 9MW2821 (anti-Nectin-4) and 9MW2921 (anti-Trop-2) to enhance targeted cancer therapies [35]. - The company is focusing on the development of dual-specific antibodies like 6MW3211 (anti-CD47/PD-L1) to improve treatment efficacy in oncology [35]. - The company is exploring the therapeutic potential of interleukins such as IL-11 and IL-33 in treating major diseases, including cancer and inflammatory conditions [36]. - The company is actively pursuing regulatory approvals, including IND applications for new drug candidates, to advance its clinical trials [36]. - The company is committed to advancing its research and development capabilities to overcome technical barriers in drug development [78]. - The company has established four technology platforms for drug discovery and development, resulting in 29 clinical approvals for 13 new products since its inception [81]. Financial Performance - The company's operating revenue for the first half of the year reached ¥89,961,372.07, a significant increase of 713.81% compared to the same period last year, primarily due to a high revenue recognition from a licensing agreement with DISC MEDICINE, INC. [42]. - The net profit attributable to shareholders was -¥413,525,055.42, showing a slight improvement from -¥423,281,278.86 in the previous year, indicating a reduction in losses [41]. - The net cash flow from operating activities was -¥321,348,781.44, which is a decline compared to -¥263,101,627.81 in the same period last year [41]. - The total assets at the end of the reporting period were ¥4,650,596,925.83, reflecting a slight increase of 0.67% from the previous year [41]. - The net assets attributable to shareholders decreased by 10.08% to ¥3,161,235,553.82 compared to the end of the previous year [41]. - The company reported a non-recurring loss of approximately -1,001,831.08 CNY from other operating income and expenses [70]. - The company reported a total of 2,009,958.09 CNY in non-recurring gains after accounting for minority interests [70]. Market and Product Development - The company is focused on the development of innovative drugs, particularly in the treatment of autoimmune diseases, which are increasingly recognized as a major health concern [47]. - The company has developed multiple monoclonal antibody products, including 9MW0113 (Mabwell's collaboration with Junshi Biosciences) and 9MW0211, targeting various medical conditions [75]. - The company has launched the monoclonal antibody 迈利舒® (9MW0311) for osteoporosis treatment, significantly reducing fracture risks in postmenopausal women [75]. - The company is expanding its market presence through strategic partnerships and collaborations in the biopharmaceutical sector [36]. - The company has signed commercialization agreements for its biosimilar product in Pakistan, Morocco, and the Philippines, and submitted registration applications in Indonesia and pre-registration in Egypt [94][99]. - The company aims to expand its international cooperation for innovative drugs, focusing on high-differentiation products like 9MW2821 and 9MW1911, which are positioned in the second tier globally [90]. - The company has established a complete industrial chain for antibody and recombinant protein drug development and commercialization [113]. - The marketing team has successfully established a sales promotion system for Adalimumab (Junmai Kang®) and Denosumab (Maili Shu®), with 172 hospitals and 955 pharmacies now included in the network [116]. - The company has signed multiple external technology licensing agreements, with a total agreement value of ¥3.56 billion, which includes sales royalties post-launch [119]. Regulatory and Compliance - The company emphasizes the importance of ensuring the accuracy and completeness of its financial reports, as stated by its responsible executives [24]. - The company is committed to maintaining high manufacturing standards, adhering to cGMP and GSP guidelines to ensure product quality and safety [36]. - The company’s production facility in Taizhou has completed construction in compliance with China GMP, US FDA cGMP, and EU EMA GMP standards, with three bulk production lines and two formulation lines [190]. - The company has implemented product recall and return management procedures to ensure patient safety, with no abnormal product recalls reported [197]. Strategic Goals and Future Outlook - The company is committed to transforming innovation from dreams into reality, aligning with its mission to explore life and benefit health [17]. - The company is positioned to capitalize on the growing demand for targeted therapies in oncology, with a robust portfolio of drug candidates [36]. - The company aims for deep domestic market promotion and flexible growth in overseas markets in 2023, establishing a multi-strategy drug pipeline [198]. - The company is leveraging its existing business network in emerging markets to achieve rapid market entry, particularly in countries along the "Belt and Road" initiative [199].

迈威（上海）生物科技股份有限公司 经核查，我们认为：公司 2023 年半年度募集资金存放与使用情况符合《上 市公司监管指引第 2 号——上市公司募集资金管理和使用的监管要求》《上海证 券交易所上市公司自律监管指引第 1 号——规范运作》以及公司《募集资金管理 制度》等法律法规、规范性文件和公司制度的规定，对募集资金进行了专户存储 和专项使用，并及时履行了相关信息披露义务，募集资金具体使用情况与公司已 披露情况一致，不存在变相改变募集资金用途和损害股东利益的情况，不存在违 规使用募集资金的情况。 综上所述，我们一致同意《关于公司<2023 年半年度募集资金存放与实际使 用情况的专项报告>的议案》。 （以下无正文） 1 / 2 迈威（上海）生物科技股份有限公司 迈威（上海）生物科技股份有限公司 独立董事关于第二届董事会第二次会议 相关事项的独立意见 根据中国证券监督管理委员会《关于在上市公司建立独立董事制度的指导意 见》《上海证券交易所科创板股票上市规则》等法律法规、规范性文件及《迈威 （上海）生物科技股份有限公司章程》《迈威（上海）生物科技股份有限公司独 立董事工作制度》等有关规定，我们作为迈威（上海）生物科技 ...

迈威（上海）生物科技股份有限公司 证券代码：688062 证券简称：迈威生物 公告编号：2023-043 迈威（上海）生物科技股份有限公司 第二届监事会第二次会议决议公告 表决结果：3 票同意，0 票反对，0 票弃权。 本公司监事会及全体监事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 一、监事会会议召开情况 迈威（上海）生物科技股份有限公司（以下简称"公司"）第二届监事会第 二次会议通知于 2023 年 8 月 18 日以电子邮件方式送达全体监事，于 2023 年 8 月 28 日以通讯表决方式召开。会议由监事会主席楚键先生主持，会议应到监事 3 人，实到监事 3 人。会议的召集、召开程序和方式符合《公司法》等法律法规 以及《迈威（上海）生物科技股份有限公司章程》的有关规定，会议决议合法、 有效。 二、监事会会议审议情况 （一）审议通过《关于公司<2023 年半年度报告>及摘要的议案》 经审议，全体监事认为公司《2023 年半年度报告》的编制、审议程序符合相 关法律法规及规范性文件的规定和要求，公司《2023 年半年度报告》的内容真 实、 ...

根据中国证券监督管理委员会于 2021 年 12 月 7 日出具的《关于同意迈威 （上海）生物科技股份有限公司首次公开发行股票注册的批复》（证监许可 [2021]3859 号），公司获准向社会公开发行人民币普通股（A 股）99,900,000 股， 发行价格为每股人民币 34.80 元，募集资金总额为人民币 3,476,520,000.00 元，扣 除与本次发行有关费用（不含增值税）人民币 173,087,827.60 元后，实际募集资 金净额为人民币 3,303,432,172.40 元。上述募集资金已于 2022 年 1 月 10 日全部 到位，安永华明会计师事务所（特殊普通合伙）对公司本次公开发行新股的资金 到位情况进行了审验，并出具了安永华明（2022）验字第 61474717_B01 号《验资 报告》。募集资金到账后，已全部存放于经公司董事会批准开设的募集资金专项 账户内。 （二）募集金额本报告期使用金额和结余金额情况 迈威（上海）生物科技股份有限公司 证券代码：688062 证券简称：迈威生物 公告编号：2023-042 迈威（上海）生物科技股份有限公司 关于 2023 年半年度募集资金存放与 实 ...

Financial Performance - The total revenue for the first quarter was CNY 4,039,353.81, representing a decrease of 0.70% compared to the same period last year[2]. - The net profit attributable to shareholders was a loss of CNY 241,105,420.80, with a basic and diluted earnings per share of -CNY 0.60[2]. - The company reported a net cash flow from operating activities of -CNY 152,672,130.25[2]. - The weighted average return on equity was -7.07%[2]. - The company reported other operating income and expenses of -CNY 799,998.56[9]. - The net profit attributable to shareholders of the parent company for Q1 2023 was -241,105,420.80 RMB, compared to -220,354,943.66 RMB in Q1 2022, indicating a decline in profitability[40]. - The total comprehensive income attributable to shareholders of the parent company for Q1 2023 was -241,682,020.95 RMB, compared to -220,605,505.84 RMB in Q1 2022, reflecting a worsening financial position[40]. - The basic and diluted earnings per share for Q1 2023 were both -0.60 RMB, compared to -0.55 RMB in Q1 2022, showing a decrease in earnings per share[40]. Revenue and Costs - Total revenue for Q1 2023 was RMB 4,039,353.81, a slight decrease of 0.7% compared to RMB 4,067,989.08 in Q1 2022[24]. - Total operating costs increased to RMB 245,010,406.95 in Q1 2023, up from RMB 224,504,606.40 in Q1 2022, representing a rise of approximately 9.1%[24]. Assets and Liabilities - Total assets at the end of the reporting period were CNY 4,653,540,396.60, reflecting a 0.74% increase from the end of the previous year[16]. - The equity attributable to shareholders decreased by 5.97% to CNY 3,305,856,055.23 compared to the previous year[16]. - Total current assets as of March 31, 2023, were RMB 2,572,510,083.80, down from RMB 2,778,057,919.49 at the end of 2022, a decrease of about 7.4%[28]. - Long-term equity investments decreased slightly from RMB 20,200,724.10 at the end of 2022 to RMB 19,399,399.58 in Q1 2023, a decline of approximately 4.0%[28]. - Non-current liabilities rose to $853,493,340.24 from $663,719,989.80, an increase of about 28.63%[33]. - The total liabilities increased to $1,353,358,914.54 from $1,108,864,451.65, which is an increase of approximately 21.98%[33]. Cash Flow - The company’s cash and cash equivalents decreased to RMB 2,252,808,708.36 as of March 31, 2023, down from RMB 2,491,034,942.29 at the end of 2022, a decline of about 9.6%[28]. - Cash inflows from operating activities in Q1 2023 amounted to 148,871,418.14 RMB, a significant increase from 7,360,391.31 RMB in Q1 2022[45]. - Cash outflows from operating activities in Q1 2023 totaled 301,543,548.39 RMB, compared to 268,181,819.30 RMB in Q1 2022, indicating higher operational costs[45]. - The net cash flow from operating activities for Q1 2023 was -152,672,130.25 RMB, an improvement from -260,821,427.99 RMB in Q1 2022[45]. - Cash inflows from investment activities in Q1 2023 were 60,303,273.40 RMB, while cash outflows totaled 315,063,627.10 RMB, resulting in a net cash flow from investment activities of -254,760,353.70 RMB[46]. - Cash inflows from financing activities in Q1 2023 were 237,826,431.33 RMB, compared to 3,432,355,563.66 RMB in Q1 2022, indicating a decrease in financing[46]. - The net increase in cash and cash equivalents for Q1 2023 was -238,234,736.75 RMB, contrasting with an increase of 3,019,205,985.51 RMB in Q1 2022[46]. - The ending balance of cash and cash equivalents as of Q1 2023 was 2,251,409,951.93 RMB, down from 3,112,750,592.03 RMB at the end of Q1 2022[46]. Research and Development - Research and development expenses totaled CNY 176,998,516.51, an increase of 12.89% year-on-year, accounting for 4,381.85% of total revenue[2]. - Research and development expenses increased to $176,998,516.51 from $156,792,322.74, marking a rise of about 12.87%[39]. Product Development and Market Strategy - The company expects to add over 200 new hospital admissions within the year, aiming for sales of approximately 250,000 units, which would generate around CNY 250 million in revenue[12]. - The company’s new product, Mai Li Shu®, was approved for market entry in Q1 2023, with expectations to achieve hospital access in over 200 locations and sales of at least 300,000 units, generating revenue of no less than RMB 180 million[26]. - The anticipated approval date for the new product Mai Wei Jian® is set for Q3 2023, with plans for aggressive market entry and sales efforts post-approval[26]. - The company is actively pursuing marketing strategies related to pricing and hospital access for its new products[26]. - The company has indicated plans for market expansion, although specific strategies and targets were not detailed in the reports[39]. - The company has not reported any new product launches or technological advancements in the current quarter[39].

证券代码：688062 证券简称：迈威生物 公告编号：2023-028 迈威（上海）生物科技股份有限公司 关于召开 2022 年度 暨 2023 年第一季度业绩说明会的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 重要内容提示： 会议召开时间：2023 年 04 月 26 日（星期三）下午 13:00-14:00 会 议 召 开 地 点 ： 上海证券 交 易 所 上 证 路 演 中 心 （ 网 址 ： http://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 投资者可于 2023 年 04 月 19 日（星期三）至 04 月 25 日（星期二）16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 ir@mabwell.com 进行提问。公司将在说明会上对投资者普遍关注的问题进行回 答。 迈威（上海）生物科技股份有限公司（以下简称"公司"）已于 2023 年 4 月 7 日发布公司 2022 年度报告，为便于广大投资者更全面深入地了解公司 2022 年度经 ...

R&D Investment and Personnel - R&D expenses totaled ¥758,611,824.45, an increase of 21.86% compared to ¥622,514,864.20 from the previous year[2] - The proportion of R&D expenses to operating income decreased by 1,100.58 basis points, from 3,836.47 to 2,735.89[2] - The company has 568 R&D personnel, representing 53.99% of the total workforce, down from 68.56%[7] - The average salary of R&D personnel increased to ¥30.67 million from ¥29.67 million[7] - Cumulatively, the company has submitted 307 patent applications in the current year, with 71 granted, including 129 invention patents and 15 utility model patents[25] - The company has 62 authorized invention patents, with 37 in China and 25 at the national stage, indicating a strong focus on innovation[30] - The company has faced cumulative losses since its establishment, with ongoing high R&D expenditures expected to continue leading to further losses in the coming years[34] - The company is actively seeking international collaborations to enhance its R&D capabilities and address clinical needs[30] Clinical Trials and Product Development - The company completed the first patient dosing in the Phase II clinical study for skin structure infection patients with 9MW2821, and the Phase I/IIa clinical study for safety, tolerability, pharmacokinetics, and preliminary efficacy has also commenced[22] - The company has received regulatory approvals for multiple clinical trial applications, including 9MW3011 for polycythemia vera and beta-thalassemia, and 9MW0113 for Crohn's disease and other indications[22] - The company has completed various clinical trials, including the approval of 9MW0113 for treating rheumatoid arthritis and other conditions in March 2022[19] - The company has established four key technology platforms for antibody drug development, including high-throughput hybridoma antibody discovery and ADC drug development, enhancing its core technological capabilities[30] - The company has 12 core products in its pipeline, with significant ongoing investments in preclinical research and clinical trials[35] - The company has made significant progress in its R&D efforts, with multiple products moving into clinical stages, indicating a robust pipeline for future growth[73] - The company has initiated clinical trials for multiple new products, including 9MW2921 and 9MW3811, indicating a robust pipeline for future growth[90] - The company has received FDA approval for the clinical trial of 9MW3011, targeting patients with polycythemia vera and beta-thalassemia[22] Production Capacity and Facilities - The production capacity for antibody drugs at the Taizhou production base is 8,000L, while recombinant protein drugs have a capacity of 4,000L[8] - The Shanghai Jinshan production base is undergoing expansion to achieve an annual production capacity of 1,000kg of antibodies, with a construction area of 50,637 square meters[8] - The production capacity expansion at the Langrun Maiwei facility in Shanghai is progressing smoothly, with two 2,000L single-use bioreactor production lines and one vial filling line installed and currently in the testing phase[17] - The company has completed the construction of a production base compliant with GMP standards in Taizhou, Jiangsu, and is building large-scale commercial production bases in Shanghai and Taizhou[97] - The company has initiated the "1,000kg antibody industrialization construction project" at its Shanghai Jinshan production base, which is designed to meet global market demands and is built according to China GMP, FDA cGMP, and EU EMA GMP standards[167] Financial Performance - The company achieved operating revenue of CNY 27.73 million in 2022, primarily from technology service income, representing a year-on-year growth of 70.88%[73] - The net loss attributable to shareholders for 2022 was ¥955,234,572.32, an increase of ¥185,647,898.86 from the previous year's loss of ¥769,586,673.46[81] - The net cash flow from operating activities for 2022 was a net outflow of ¥719,171,146.41, which is an increase in outflow of ¥296,681,170.10 compared to ¥422,402,976.31 in 2021[81] - The company's total assets at the end of 2022 were ¥4,619,475,225.93, a significant increase of 189.57% from ¥1,595,272,932.19 at the end of 2021[81] - The diluted earnings per share for 2022 was -¥2.44, slightly improved from -¥2.57 in 2021[83] Market Strategy and Sales - The company has established a self-operated sales team for its rheumatology and immunology product line, achieving a sales revenue of 9.96 million yuan in May 2022 for its first product, Adalimumab (Junmai Kang®)[23] - The marketing center has been structured to enhance product positioning, market strategy, and post-marketing medical research, focusing on evidence-based medicine[23] - The company plans to expand its product lines with an initial allocation of approximately 280 personnel for each new line to support marketing and after-sales management[23] - The company has achieved hospital access in 105 hospitals across 18 provinces, laying a solid foundation for future growth[23] - The company expects to add over 200 new hospital entries for Junmai Kang® in 2023, aiming for sales of approximately 250,000 units and revenue of about 250 million yuan[102] Regulatory Compliance and Quality Management - The company has established a quality management system compliant with post-marketing production requirements, successfully passing inspections by the National Medical Products Administration (NMPA) for its subsidiaries in June 2022[13] - The drug safety monitoring system has been established to comply with national regulations, ensuring the identification and management of adverse drug reactions throughout the drug lifecycle[18] - The drug safety committee has been established to oversee major risk assessments and ensure compliance with legal requirements in drug safety monitoring[18] - The company has implemented a product recall management procedure, categorizing recalls into three levels based on severity, ensuring timely response to safety concerns[192] Strategic Partnerships and Collaborations - The company is focusing on expanding its international market presence, particularly in emerging markets and along the "Belt and Road" initiative, to enhance its global brand influence[95] - The company has signed formal agreements covering seven countries for the commercialization of 9MW0113, with potential milestone payments totaling 12.75 million USD[95] - The company has established an international business department to facilitate overseas market promotion and global business cooperation[95] - The exclusive licensing agreement with DISC Medicine for the 9MW3011 project could yield up to USD 412.5 million in upfront and milestone payments, including a non-refundable upfront payment of USD 10 million[144] Innovation and Technology Development - The company emphasizes a modular approach in drug development, enhancing innovation and efficiency through structured management of different research phases[162] - The company focuses on independent research and development, supplemented by collaborative and commissioned research to ensure comprehensive implementation of technological innovation[164] - The company is actively advancing marketing-related work, including pricing and access strategies for Mai Li Shu®[148] - The company is leveraging commercial health insurance to support the high return lifecycle of innovative drugs, as part of a broader strategy to enhance the pharmaceutical industry's development[173]

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